Security and reliability of CUSTOMBONE cranioplasties: A prospective multicentric study.

BACKGROUND: Repairing bone defects generated by craniectomy is a major therapeutic challenge in terms of bone consolidation as well as functional and cognitive recovery. Furthermore, these surgical procedures are often grafted with complications such as infections, breaches, displacements and rejections leading to failure and thus explantation of the prosthesis. OBJECTIVE: To evaluate cumulative explantation and infection rates following the implantation of a tailored cranioplasty CUSTOMBONE prosthesis made of porous hydroxyapatite. One hundred and ten consecutive patients requiring cranial reconstruction for a bone defect were prospectively included in a multicenter study constituted of 21 centres between December 2012 and July 2014. Follow-up lasted 2 years. RESULTS: Mean age of patients included in the study was 42±15 years old (y.o), composed mainly by men (57.27%). Explantations of the CUSTOMBONE prosthesis were performed in 13/110 (11.8%) patients, significantly due to infections: 9/13 (69.2%) (p<0.0001), with 2 (15.4%) implant fracture, 1 (7.7%) skin defect and 1 (7.7%) following the mobilization of the implant. Cumulative explantation rates were successively 4.6% (SD 2.0), 7.4% (SD 2.5), 9.4% (SD 2.8) and 11.8% (SD 2.9%) at 2, 6, 12 and 24 months. Infections were identified in 16/110 (14.5%): 8/16 (50%) superficial and 8/16 (50%) deep. None of the following elements, whether demographic characteristics, indications, size, location of the implant, redo surgery, co-morbidities or medical history, were statistically identified as risk factors for prosthesis explantation or infection. CONCLUSION: Our study provides relevant clinical evidence on the performance and safety of CUSTOMBONE prosthesis in cranial procedures. Complications that are difficulty incompressible mainly occur during the first 6 months, but can appear at a later stage (>1 year). Thus assiduous, regular and long-term surveillances are necessary.

Surgical preference regarding different materials for custom-made allograft cranioplasty in patients with calvarial defects: Results from an internal audit covering the last 20 years.

BACKGROUND: Secondary cranioplasty (CP) plays a key role in restoring cranial vault anatomy and normal brain function following decompressive craniectomy (DC). The scientific literature provides only fragmentary information regarding the best timing and material for CP, making a direct comparison of different materials difficult. OBJECT: To identify and report according to STROBE guidelines local trends in choice of materials for CP, complications rate and surgical outcomes. METHODS: We conducted an audit on secondary CP covering the last 20 years of surgical practice at our Institution. Custom-made CP used over the years were made of: porous hydroxyapatite (PHA), polymetylmethacrylate (PMMA), polyetheretherketone (PEEK), acrylic and titanium. The primary endpoint of this study was the incidence of postoperative complications, such as: implant infection, fracture and dislocation. Secondary endpoints were the followings: patients satisfaction with cosmetic result, rate of implant integration, and long-term neurological outcome. RESULTS: A total of 218 patients were included, given the predominance of PHA (Group A) or PMMA (Group B) CP, a direct comparison was made only between those two groups. Overall reoperation rate was 6.5% versus 28%; implants' osseointegration rate was of 69% versus 24%; satisfaction rate was 66% versus 44%, in Group A and B respectively. CONCLUSIONS: This single-centre study provides Level 3 evidence that PHA yields better outcomes than PMMA CP. Designing a management algorithm for planning and executing CP is difficult for clinical and organizational reasons; till a widespread consensus is reached, neurosurgeons with subspecialty interest in neurotrauma should favor pragmatism and patient safety over costs.

Mid-term progressive loosening of hydroxyapatite-coated femoral stems paired with a metal-on-metal bearing.

BACKGROUND: Several hydroxyapatite (HA)-coated femoral stems from a single manufacturer were identified to have aseptically loosened at mid-term follow-up despite prior radiographic appearance of osseointegration. Possible causes and associated risk factors for stem loosening were explored through radiographic review and implant retrieval analysis. METHODS: Forty-six retrieved hip stems (Corail, DePuy-Synthes) were identified and grouped by bearing type: metal-on-metal (MoM), metal-on-polyethylene, and ceramic-on-ceramic. Stem lucency was graded on post-operative radiographs up to the time of revision. Stems were examined for stripping of the HA coating, taper corrosion, and bearing wear in metal-on-metal cases. Patient demographics, implant design features, and perioperative data were collected from electronic databases and patient charts. RESULTS: Aseptic loosening occurred in 37% of cases examined. MoM bearings were associated with 7.25 times greater risk of loosening compared to other bearing types. Stem radiolucency was more prevalent for MoM cases and, although not statistically significant, demonstrated progressive lucency. Taper corrosion appeared more severe for MoM cases and correlated with proximal stem radiolucency. Removal of the HA coating from the stems was associated with both taper corrosion and MoM bearing wear. Length of implantation was a confounding factor for the MoM cases. CONCLUSION: This study has demonstrated a high risk of mid-term loosening of previously osseointegrated HA-coated femoral stems when paired with a MoM bearing. The mechanism of loosening appears progressive in nature and related to the MoM bearing, possibly interacting with the HA coating. If such loosening is recognized early, rapid revision may allow for retention of the femoral stem.

Comparative study of nanohydroxyapatite microspheres for medical applications.

This study concerns the preparation, physical, and in vitro characterization of two different types of hydroxyapatite (HA) microspheres, which are intended to be used as drug-delivery systems and bone-regeneration matrices. Hydroxyapatite nanoparticles (HA-1 and HA-2) were prepared using the chemical precipitation synthesis with H(3)PO(4), Ca(OH)(2), and a surfactant, SDS (sodium dodecyl sulfate), as starting reagents. The HA powders were dispersed in a sodium alginate solution, and spherical particles were obtained by droplet extrusion coupled with ionotropic gelation in the presence of Ca(2+). These were subsequently sintered to produce HA-1 and HA-2 microspheres with a uniform size and interconnected microporosity. Both powders and microspheres were characterized using FTIR and X-ray diffraction. Moreover, SEM and mercury intrusion porosimetry were used to analyze the microspheres, and TEM was used to analyze the powders. Results showed that pure HA and mixtures of HA/beta-TCP in the nanometer range and needlelike shape were obtained for HA-1 and HA-2 powders, respectively. Neutral Red, scanning electron microscopy and confocal microscopy were used to evaluate the behavior of osteoblastic-like MG-63 cells cultured on HA microspheres surfaces for 7 days. Results showed that good adhesion and proliferation of osteoblasts on the HA microspheres surface. Cells built bridges between adjacent microspheres, forming microspheres-cells clusters in both types of materials.

Hydroxyapatite dip coated and uncoated titanium poly-axial pedicle screws: an in vivo bovine model.

STUDY DESIGN: A 1-year-old calf was implanted with titanium pedicle screws either uncoated (n = 7) or coated with hydroxyapatite (n = 7) by the dipping method on the pedicles of vertebrae (t10-l3). OBJECTIVE: To evaluate biomechanical and histomorphologic responses to titanium pedicle screws uncoated and coated with hydroxyapatite. SUMMARY OF BACKGROUND DATA: Failure of fixation caused by loosening of pedicle screws is a problem in spinal surgery. Enhancement of the fixation ability of screws by coating with biocompatible materials may improve prognosis of surgery. METHODS: The calf was euthanized 4 months after implantation for determination of insertion and extraction torques for screws, and histologic and scanning electron microscopic examinations of areas screw embedded. RESULTS: Insertion torques did not differ by the kind of screws (99 +/- 5.7 Ncm). However, extraction torques for screws coated with hydroxyapatite were higher than for screws uncoated (249 vs. 133 Ncm, P < 0.01). As compared with uncoated screws, implanted areas for hydroxyapatite-coated screws were denser, had more cracks, and provided better bonding. Fibrous tissue and new bone formation were observed around the areas of uncoated and hydroxyapatite-coated screws embedded, respectively. CONCLUSIONS: Hydroxyapatite coating of titanium pedicle screws by the dipping method improved fixation and vertebral bone-implant interface, suggesting a decreased risk of a screw-loosening problem.

[Experimental study of the biocompatible and osteoinductive behavior of the hydroxyapatite/ultra-high molecular weight polyethtlene composite].

OBJECTIVE: To compare the biocompatibility and osteoinductive behavior of HA (hydroxyapatite) and HA/UHMWPE (ultra-high molecular weight polyethtlene) composite in orbital implantation. METHODS: Osteoectomy of the upper orbital rim was perform on 24 adult New Zealand rabbits. The animals were randomly divided into 4 groups with 6 of each. The HA, HA/UHMWPE composite or UHMWPE (10 mm x 10 mm x 3 mm in size) was implanted to the upper orbital defect of the animal in respective group. Animals were sacrificed at 1, 4, 8, 12 weeks. Histopathologic sections of the implants were evaluated and compared with light and transmission electron microscopy study. RESULTS: During the experimental period of 12 weeks, there was no implant extrusion or displacement. In the groups of HA and HA/UHMWPE composite, vascular ingrowth and fibroblasts were observed shortly and osteocytes were seen at 8 weeks. Calcium deposition of the implants showed a laminar fashion at 12 weeks. In the group of UHMWPE, fibrous membranes were seen around the implant at 1 week. Transmission electron microscopy study showed that in the HA and HA/UHMWPE groups, fibroblasts and vascular ingrowth could be seen, but osteocytes were not observed. CONCLUSION: HA/UHMWPE composite demonstrated biocompatibility and osteoinductive property. It would be a good substitute for bone, particularly for orbital bone.

Impacted morselized cancellous bone: mechanical effects of defatting and augmentation with fine hydroxyapatite particles.

Geotechnical engineering testing techniques were used to study the mechanical properties of morselized cancellous bone (MCB) and the effects of defatting and augmentation with fine hydroxyapatite (HA) particles. Bovine and human cancellous bone was morselized, rinsed, and manually squeezed to remove excess fluid, producing a standard surgical MCB sample that was also used as a control. Some of the MCB was defatted with heat and detergent and mixed with HA particles in ratios ranging from 0% to 100% HA. Compaction tests were used to determine the effects of moisture content and the amount of MCB that can be packed into a confined space. One-dimensional consolidation tests were used to determine the uniaxial strain behavior, confined modulus, and steady-state creep rate. The compaction tests demonstrated that defatting and adding HA particles significantly increased density. The one-dimensional consolidation tests showed that strain was decreased, modulus was increased and the creep rate was decreased by defatting and adding HA.

Effect of process parameters on the characteristics of porous calcium phosphate ceramics for bone tissue scaffolds.

Porous hydroxyapatite (HA) has already been widely used as a bone substitute due to its similarity with the mineral part of the bone. In this work, cylindrical tablets with micro and macro porosity were produced from stoichiometric and deficient hydroxyapatites by using naphthalene as porosifier agent. The influence of the processing parameters such as Ca/P ratio of start material, calcination temperature, and naphthalene content on the characteristics of porous calcium phosphate tablets was evaluated. Three mineral phases-HA, alpha-TCP (alpha tri-calcium phosphate), and beta-TCP (beta tricalcium phos-phate)-with variable contents were identified by x-ray diffraction (XRD) and Fourier-transformed infrared spectroscopy (FT-IR). Image analysis and density measurements were used to characterize sample porosity. As expected, the total porosity of the calcinated material is not dependent on the stoichiometry of the precursor hydroxyapatite. For calcium-deficient hydroxyapatite, the increase in naphthalene content contributes to stabilize alpha-TCP phase, altering the relative phases content.

[Cellular culture of osteoblasts and fibroblasts on porous calcium-phosphate bone substitutes]. / Culture cellulaire d'ostéoblastes et de fibroblastes sur substituts osseux poreux en phosphate de calcium.

PURPOSE OF THE STUDY: Calcium phosphate ceramics are synthetic bone substitutes able to fill in bone destruction as a support of the bone growth. This work consisted in an in vitro assessment of osteoblasts and fibroblasts cultures on macroporous calcium-phosphate bone substitutes to analyze the interaction between cells and bone substitute. MATERIALS AND METHODS: The macroporous ceramic was composed of 70% hydroxyapatite and 30% tri-calcium phosphate with known mechanical and physico-chemical properties. Three compounds were processed with different size of macropore and with or without microporosity on their surface. Cells were seeded on discs measuring 10 mm in diameter and 2 mm in thickness. Cellular viability was evaluated by the MTT test for every stage of observation. An histological study to observe the invasion in the depth of discs was performed. Scanning electron microscopy was used to analyze the cellular comportment in contact with the surface of substitutes. RESULTS: An exponential cellular growth was effective on each substitute with the two cellular types. Cells spread on the surface of the compounds covering macropores and colonized the depth of the discs. A size of macropore of 300 microm or more seemed to support this invasion. 15 microm sized interconnections appeared to be effective to allow cell migration between macropores. The cell proliferation was similar on substitutes with or without microporosity. CONCLUSION: Biomaterials currently used as bone substitute are more or less osteoconductive but they have no osteoinductive property. A hybrid association of calcium-phosphate ceramic with osteogenic cells should promote the development of a calcium phosphate compound with osteoinductive capacity.

[Quality assurance of powders for bioceramic applications with image analysis]. / Qualitätssicherung von Pulvern für biokeramische Anwendungen mittels Bildanalyse.

Bone substitute materials are very demanding with respect to their quality, in particular, a high toughness and durability are required. In case of producing the composites by sintering of mechanically generated powder mixtures, a high efficiency of mixture is demanded, too. The characterisation of such particle systems is difficult. An effective method is the image analysis supported by statistical evaluation of both the size and the shape distributions of particles and agglomerates. As it is proved by first results, powder mixtures of hydroxyapatite can be described by the geometry of voids in the agglomerate structure using the shape factor weighted by area of the respective image object. As a measure of the efficiency of mixture, the degree of reproducibility was introduced.

Push-out strength of hydroxyapatite coated by sputtering technique in bone.

Hydroxyapatite was coated with 1 microm thickness on titanium columns of a length of 10 mm, an outer diameter of 4.0 mm by radio frequency magnetron sputtering. The hydroxyapatite coating titanium columns were implanted in the diaphysis of femora of 3 adult dogs, and push-out test was carried out after 2, 4 and 12 weeks of implantation using a testing machine. The interface of bone/column was observed histologically after the test. At 12 weeks the push-out strengths of coating and non-coating columns were 3.5 and 1 MPa, respectively. Histological observation indicated a formation of thin connective tissue with 5-30 microm thickness at the interface of the bone/column. No inflammation was observed during the implantation periods.

Material removal during the sliding of hydroxyapatite against UHMWPE.

Hydroxyapatite has been rubbed against ultra-high-molecular-weight-polyethylene (UHMWPE) under calcium-containg aqueous solutions. Further, hardness tests were carried out in air and in calcium-containing solutions whose pH ranged from pH 5 to pH 9. Hardness was found to vary with pH with a peak at around pH 7, i.e. - a chemomechanical effect was observed. Wear tests consisted in sliding hydroxyapatite samples against a UHMWPE disk for eight hours when lubricated by the same solutions as those used for the hardness tests. Volume loss, pH and calcium concentration were measured for up to 8 hours of sliding. Linking wear tests results with hardness results and supersaturation levels, it was concluded that two wear mechanisms occurred. A chemical mechanism depending on supersaturation occurred at the early stages of sliding. The wear rate was essentially independent of hardness during this stage. After a few hours, depending on the supersaturation of the lubricant, the chemical mechanism turned into a chemomechanical mechanism dependant on hardness.

Reassessment of long-term use of dense HA as dental implant: case report.

Dense hydroxyapatite (HA) is widely believed to be unsuitable for clinical use as dental implants due to its poor mechanical properties, although it has excellent biocompatibility and is chemically stable and nonresorbable in vivo. However, the case in this article is one in which the patient's dense HA implants are still stable and in good functional condition 16.5 years after he received four pieces of a one-piece dense HA implant in both sides of his lower molar regions. Furthermore, almost no radiolucency is evident along the root portions of the implant sites in the bone. These findings imply that dense HA can be clinically useful and should be reevaluated as a dental implant material.

Vitamin K status and bone health: an analysis of methods for determination of undercarboxylated osteocalcin.

Recent studies suggest that fracture risk is associated with increased undercarboxylated osteocalcin. Methods use differences in binding of undercarboxylated and fully carboxylated osteocalcin to hydroxyapatite or barium sulfate. We evaluated these methods and found that results varied with the amount and preparation of the salts. Furthermore, patient samples with differing amounts of total osteocalcin could not be directly compared. Errors in the determination of undercarboxylated osteocalcin were minimized by expressing data as the percent of the total osteocalcin in the sample, and correcting for the basal level of osteocalcin using a polynomial equation derived from multiple binding curves. Errors from 5-15% in estimation of undercarboxylated osteocalcin were observed without both of these corrections. When differing types of assays were employed (RIA, intact, N-terminal), results also were affected. In normal adults and children and in patients on long-term warfarin therapy, the percent osteocalcin not bound to hydroxyapatite was lower when measured with an intact assay than by a polyclonal RIA. Differences were related to the amount of N-terminal osteocalcin fragments, which had low affinity for hydroxyapatite and resulted in variable overestimation of undercarboxylated osteocalcin. In a kit specific for uncarboxylated osteocalcin, we found good discrimination between carboxylated and uncarboxylated intact osteocalcin. However, the assay detected large osteocalcin fragments and overestimated their concentration by up to 350%. Values for uncarboxylated osteocalcin were not different in patients on coumadin compared with normal adults with this kit, but when normalized to the total intact osteocalcin, percent uncarboxylated osteocalcin was greater in patients on coumadin than in controls, as would be expected. Kit values for uncarboxylated osteocalcin in normal children were higher than intact values in the same subject, because of the increased reactivity of the kit toward circulating fragments that were elevated in children. Thus, for estimation of undercarboxylated osteocalcin, care must be taken to standardize the hydroxyapatite or barium sulfite used for binding, to correct for the basal level of osteocalcin in the sample, to use immunoassays that do not detect small fragments, and to express the results as the percent of the total osteocalcin in the sample. Without these precautions, the assessment of undercarboxylated osteocalcin is not reliable.

Improved fixation of porous-coated versus grit-blasted surface texture of hydroxyapatite-coated implants in dogs.

We inserted, in 8 dogs, implants with either porous-coated or grit-blasted titanium surface and coated with hydroxyapatite (HA) into trabecular bone in the proximal humerus, using a 1 mm gap model. After 25 weeks, push-out tests showed that energy absorption for porous-coated implants was twice that of grit-blasted implants, whereas shear stiffness was reduced by one fifth, indicating a stronger fixation of porous-coated implants. Macroscopically, all grit-blasted implants had delamination of the HA coating, whereas porous implants failed mostly at the HA-tissue interface. Porous-coated implants had 47% bone ingrowth and grit-blasted implants 70% (p = 0.02), however, no difference in absolute surface area was found. Part of the HA coating was resorbed during the implantation period as regards volume and thickness. HA coverage was more reduced on porous-coated than on grit-blasted implants (p = 0.01). No foreign-body reaction or osteolysis was seen. An important finding was that one fifth of the surface with complete resorption of HA coating was replaced by newly formed bone.

Development of hybrid type artificial bone marrow using sintered hydroxyapatite.

In vivo inducement of hybrid-type artificial bone marrow with hemopoietic inductive microenvironment (HIM) in sintered hydroxyapatite (HA) chamber was carried out. This research is important to disclose the mechanisms of hemopoiesis and is useful for clinical application. In the evolution of vertebrates, cartilage of the inner skeleton changed into bone, having biomechanical properties to form bone marrow cavities. The hemopoietic nests immigrated into the cavities from the spleen. We should be able to induce hemopoietic nests in a hydroxyapatite chamber in place of bone, if we can find optimal structural conditions. Therefore, we tried to artificially induce a hematopoietic field in muscles using sintered porous tubular hydroxyapatite and new type hydroxyapatite plate made by high-pressure gas technique. As a result, not only in the pore sites of tubular hydroxyapatite artificial bone, but at the surface of the new type hydroxyapatite plate implanted in the dorsal muscles, marked differentiation of bone marrow cell clusters of the hematopoietic field could be observed.

Synthesis of bioactive coatings on Ti substrates using glass enamel.

Bioactive coatings on titanium can be prepared by dispersing hydroxyapatite particles into a borosilicate glass enamel doped with TiO2. Adhesion of the coating is obtained when the titanium substrate has been preoxidized before enameling in such a way as to form a continuous TiO2-layer. Adhesion results from the diffusion of this TiO2-layer into the liquid glass during enameling. The evolution of the diffusion zone was followed by scanning electron microscopy and electron probe microanalysis. Adhesion disappears after a critical time of firing which corresponds to the completion of the dissolution of the TiO2-layer by the glass. The borosilicate glass wets the hydroxyapatite particles and adheres strongly to them after cooling.

Adhesion properties of plasma sprayed hydroxylapatite coatings for orthopaedic prostheses.

Using Air Plasma Spraying (APS) and Vacuum Plasma Spraying (VPS) techniques, hydroxylapatite (HA) and mixtures of HA and titanium (Ti) were deposited on a Ti6A14V alloy (and on an AISI 316L steel) subjected to different surface treatments. The deposits were investigated for their crystallinity, thickness, and adhesion properties. Higher adhesion values were obtained with VPS rather than with APS. By utilising VPS, the deposition conditions were selected in order to achieve crystallinity values between 70 and 90%. The adhesion results depend on the crystallinity (increasing with its decrease), on the thickness (decreasing slightly with its increase) and especially on the surface finish of the metallic substrate. A porous Ti precoat was more effective than either chemical etching in HCl or sandblasting; sandblasting being the least effective. In particular, the double deposits consisting of a porous Ti precoat and a successive layer of HA proved to be most interesting for their higher adhesion properties and for their capability of providing primary stability due to the presence of the HA and secondary stability, in the case of its reabsorption, due to the porous metal.

Preparation and characterization of porous apatite ceramics coated with beta-tricalcium phosphate.

Hydroxyapatite (Ca10(PO4)6(OH)2; HA) is one of the most biocompatible materials with bones, and porous HA is promising bone substitute materials for clinical applications. While there are reports that beta-tricalcium phosphate (Ca3(PO4)2; TCP) has higher resorbability than HA when the material is implanted in a bone defect. In the present study, porous HA coated with beta-TCP was prepared by our unique method. The porous HA of about 60% porosity with interconnecting pore structure was soaked in diammonium hydrogen phosphate solution, and then the HA was sintered at 900 degrees C for 3 h. beta-TCP was revealed by X-ray diffractometry on the surface of porous HA. It was possible to control the content of surface-formed beta-TCP arbitrary by varying the concentration of the solution. The obtained HA coated with 33 wt% beta-TCP (33TCP) had about 60% open porosity with the pore size from 150 to 400 microns. The average compressive strength of this porous ceramics was 17.5 MPa. Surface coated HA with beta-TCP deprived of the brittleness in handling. The weight of HA implanted into muscles was increased obviously at 4 weeks because of formation of carbonate hydroxyapatite on the surface of HA. The weight of 33TCP was scarcely changed up to 12 weeks, but the weight tended to increase at 24 weeks. The carbonate hydroxyapatite was not formed on 33TCP at 4 weeks, but formed on it at 24 weeks. Therefore beta-TCP coated porous HA behaved like beta-TCP initially after implantation, and then behaved like HA.